NDA 020041

ICU MEDICAL INC

FDA Drug Application

Application #020041

Documents

• Letter: 2002-08-21
• Letter: 2004-05-27

Application Sponsors

NDA 020041

ICU MEDICAL INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

15% (15GM/100ML)

0

AMINOSYN II 15% IN PLASTIC CONTAINER

AMINO ACIDS

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1991-12-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1995-04-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1994-07-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1996-08-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1995-08-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1997-03-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1996-08-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1997-05-05	STANDARD
LABELING; Labeling	SUPPL	11	AP	2002-08-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	2002-11-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	2003-01-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	2007-04-27	N/A

Submissions Property Types

SUPPL	2	Null	0
SUPPL	4	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	20	Null	4

CDER Filings

ICU MEDICAL INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20041
            [companyName] => ICU MEDICAL INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMINOSYN II 15% IN PLASTIC CONTAINER","activeIngredients":"AMINO ACIDS","strength":"15% (15GM\/100ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"AMINOSYN II 15% IN PLASTIC CONTAINER","submission":"AMINO ACIDS","actionType":"15% (15GM\/100ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)